The presence of deleterious or undesirable material, e.g., potentially pathogenic viruses and/or microorganisms such as bacteria, is of great concern during many protocols, particularly those involving surgery, testing of bodily fluids, and/or cell culturing. For example, the introduction of disease causing material such as microorganisms and/or endotoxins into a patient, e.g., through administration of a contaminated fluid, or by a failure to follow strict aseptic techniques during invasive procedures, may have serious, and possibly fatal, ramifications for the patient. Additionally, those who handle the contaminated fluid and/or care for the patient may also face health risks resulting from exposure to the pathogens. Furthermore, the presence of microorganisms may adversely affect cell cultures and/or pose a health threat to laboratory technicians who handle the contaminated fluid or the fluid processing equipment.
While a number of procedures and/or reagents for inactivating and/or killing microorganisms are known, they have suffered from a number of deficiencies, including toxicity to the patient and/or adverse affects on the disinfected or sterilized fluid. Moreover, some other procedures and/or reagents, for example, including those disclosed in International Publication Nos. WO 92/04031, WO 93/06911, and WO 92/04061, require a sophisticated, labor intensive effort to carry out disinfection safely and effectively, and they may not be suitable for a wide variety of protocols.
There are other protocols that involve the removal or depletion of deleterious or undesirable material that could be beneficially combined with a disinfection and/or sterilization protocol. For example, with respect to bodily fluids such as blood, since blood and blood components may include varying numbers of white blood cells (leukocytes), which may cause undesirable effects when administered to a patient, blood processing techniques may also include leukocyte depleting the blood or blood components, e.g., by passing the blood or blood components through a leukocyte depletion device. Since blood may also include potentially pathogenic microorganisms such as bacteria, e.g., Yersinia enterocolitica, and/or viruses, it would be advantageous to provide a sterilization procedure that is compatible with a leukocyte depletion protocol.
Accordingly, there is an unaddressed need in the art for a method and system that is suitable for a wide variety of microorganism and/or virus elimination, reduction, or inactivation protocols. Additionally, there is a need for a contamination reduction protocol that is easy to carry out, and does not require extensive training of the personnel who will be carrying out the protocol. Moreover, it would be desirable to provide a disinfection and/or sterilization method and system that is compatible with other protocols, especially blood processing protocols.
These and other advantages of the present invention will be apparent from the description as set forth below.